Amit Pruthi1, Maneesh Baghi2, Ashok Rattan3* and Sanjeev Vashishta4
1Head Corporate Quality, Pathkind Labs, Gurgaon, India
2Director, Regional Reference Laboratory, Pathkind Labs, Gurgaon, India
3Advisor, Pathkind Labs, Gurgaon, India
3Managing Director and Chief Executive Officer, Pathkind Labs, Gurgaon, India
*Corresponding Author: Ashok Rattan, Professor, Advisor, Pathkind Labs, Gurgaon, India.
Received: July 14, 2020; Published: September 26, 2020
On the last day of last year, China informed World Health Organisation was a cluster of pneumonia cases in Wuhan, caused by a novel coronavirus, which was identified as SARS CoV 2 based on sequences of viral agent available by 10th January 2020 and RT PCR tests developed to identify this RNA virus. The disease caused by this virus was labelled as Covid 19. The rapid spread of this virus from China to all parts of the world including India, led this outbreak to be labelled as a pandemic.
In January 2020, India had only one laboratory testing for Covid 19, at the Indian Council of Medical Research’s National Institute of Virology, Pune. In Mid May, the testing facilities had been ramped upto 550 laboratories, both in the government and private set up, across the country, performing molecular tests for diagnosis of Covid 19 - an unparallel achievement in the history of Indian health system.
In the absence of an effective treatment, prevention is the best strategy, which resolves around testing. RT PCR for Covid 19 involves multiple complex steps. This paper describes the minimal steps each performing laboratories must take to ensure quality in their testing. It is essential that testing laboratory verify manufacturer’s claim and perform ongoing monitoring of tests to ensure that reliable and reproducible results are available to decision makers to make evidence based informed decisions for containment of this infection. While EQAS has been announced, but no sample has yet been circulated. Interlaboratory comparison should be encouraged between ICMR designated Reference laboratories and other performing laboratories.
Keywords: Severe Acute Respiratory Syndrome (SARS); Covid 19; ICMR
Citation: Ashok Rattan., et al. “How Reliable is Your Covid 19 Tests? Need to Validate and Verify Covid 19 Tests in the Laboratory Before Clinical Use". Acta Scientific Microbiology 3.10 (2020): 75-80.
Copyright: © 2020 Ashok Rattan., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.